đź“‹ FDA Reference
winged fistula needle
Gambro
Summary: The winged fistula needle is a medical device used primarily in dialysis settings to access a patient's vascular system. It is commonly used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K760935 ↗
Decision Date
November 19, 1976
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The winged fistula needle by Gambro was cleared through the FDA 510k pathway on November 19, 1976. It is classified as a Class 2 device under product code KOC.
What It Is
The winged fistula needle is a specialized needle designed for vascular access in patients undergoing dialysis. It features a winged design that allows for easier handling and stabilization during insertion. The needle is typically used to connect the patient's blood circulation to the dialysis machine, facilitating the removal and return of blood during treatment.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients with chronic kidney disease requiring hemodialysis. Nephrologists and dialysis nurses use the winged fistula needle to access arteriovenous fistulas or grafts, which are surgically created connections between an artery and a vein. It is crucial for ensuring efficient blood flow during dialysis sessions.
Indications for Use
The winged fistula needle is indicated for use in patients who require vascular access for hemodialysis. It is specifically designed for accessing arteriovenous fistulas or grafts, which are common in patients with end-stage renal disease.
Practical Considerations
The winged fistula needle comes in various sizes to accommodate different patient needs and anatomical considerations. It is important to ensure compatibility with the dialysis machine and to use proper technique to minimize complications such as infiltration or hematoma.
Related Literature
The linked study focused on the use of bipolar diathermy in distal hypospadias repair, not directly related to the winged fistula needle. However, it highlights the importance of precision tools in surgical procedures. The study found that bipolar diathermy was effective for dissection, but the findings are limited to a specific surgical context unrelated to dialysis.
Frequently Asked Questions
What is the winged fistula needle used for?
It is used for vascular access in hemodialysis, connecting the patient's blood circulation to the dialysis machine.
What specialties typically use this device?
Nephrology and dialysis nursing are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring hemodialysis, specifically for accessing arteriovenous fistulas or grafts.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.